Let's see if we can move past my faux pas, using "B/R combo drug" when "brilacidin alongside SOC" was what I should have said. I'm sufficiently humbled and adequately educated, thank you.
I don't need you to repeat it but this surprises me....
"IPIX could apply for EUA of brilacidin alongside SOC without input from any of the manufacturers of SOC drugs such as remdesivir or dexamethasone"
.....especially given that the SOC is not defined. Maybe that's my issue.
In looking at the EUA issued to Baricitinib I noted that it was trialed with and approved for use "in combination with remdesivir" specifically. Lilly asked that it be granted the EUA for the drug to be used alone but the FDA said it saw no adequate evidence that it qualified without the remdesivir.
As YOU might suspect the Center for Drug Evaluation and Research (CDER) Review didn't include any form of agreement with Gilead. The lengthy document didn't even mention Gilead. I don't understand it but I accept it.
The Supply Information section, which focused solely on Baricitinib, showed extreme care on the FDA's part to assure availability of the drug, which is approved for other uses. The numbers are thoroughly redacted but the FDA made a concerted effort to secure the data needed (inventory, production capacity, dosages) to assure that supply of Baricitinib was or could be adequate. Again as you might expect (and I fail to grasp) the issue of adequate remdesivir wasn't mentioned. It will be interesting to see what IPIX has for supply support should an application be submitted.
So I'm TOTALLY convinced at this point that IPIX could apply for EUA of brilacidin alongside Remdesivir without any input from Gilead.
Now I'm not convinced that IPIX could secure an EUA for "brilacidin in combination with SOC" without the SOC being specified.
I'm tryin ta think but nuttin happens......Curly
